(175 days)
The SURGIMESH®XB - Skirted mesh is intended for use in the reinforcement of tissues during surgical repair.
The SURGIMESH®XB-Skirted is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The silicone layer minimizes the tissue attachment to the mesh in the case of direct contact with the viscera
The SURGIMESH®XB - Skirted surgical mesh is a non-absorbable, synthetic mesh, made of non-knitted, non-woven fibers of polypropylene, one surface of which is coated with silicone. The use of SURGIMESH®XB - Skirted mesh provides reinforcement of soft tissues. On the opposite side, the silicone layer minimizes tissue attachment to the mesh in case of direct contact with the viscera. The SURGIMESH®XB - Skirted mesh is supplied sterile and is available in anatomic forms in order to meet individual surgeons' needs.
More specifically, the SURGIMESH® XB - Skirted mesh is composed of a layer of non-woven, non-knitted material made from polypropylene (i.e., SURGIMESH®XB), a skirted part made from polypropylene (i.e., SURGIMESH®WN) linked with the first layer by sewing a PVDF thread into the two parts with a layer of silicone (equivalent to SURGIMESH® XB product material).
This document describes the premarket notification 510(k) for the SURGIMESH®XB - Skirted surgical mesh. The provided text outlines the device's characteristics, intended use, and the performance testing conducted to demonstrate substantial equivalence to predicate devices, rather than a study against a specific set of acceptance criteria with human readers or standalone algorithm performance.
Here's an analysis of the available information regarding acceptance criteria and supporting studies, formatted as requested, and noting where information is not present in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Not Explicitly Stated but Inferred from Testing Standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device must be biocompatible according to ISO 10993-1 standards. | Device demonstrated biocompatibility per ISO 10993-1 standards. |
| Sterilization Validation | Device must be sterile according to ISO 10993-7, ISO 11137-1, ISO 14937, and USP 28 standards. | Device demonstrated sterility per listed standards. |
| Product Packaging | Packaging must have appropriate sealing characteristics according to ISO 11607. | Packaging demonstrated appropriate sealing characteristics per ISO 11607. |
| Device Structure & Material Characterization | Device specifications (mechanical and material characteristics) must be substantially similar to predicate devices based on ISO 5084, ISO 3801, ISO 9073-3, ISO 9073-4, ISO 9073-7, ISO 13934-1, and ISO 13938-1 standards. | SURGIMESH®XB - Skirted specifications are substantially similar to identified predicate device specifications. |
| Functionality/Intended Use | Device must function as intended. | In all instances, the SURGIMESH®XB - Skirted functioned as intended and the results observed were as expected. |
| Substantial Equivalence | Device must be substantially equivalent to identified predicate devices. | The device was determined to be substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states "Preclinical testing was conducted" but does not detail the number of units or samples tested for each criterion.
- Data Provenance: The studies were preclinical testing conducted by Aspide Medical. The location of these tests (e.g., country of origin) is not explicitly stated, but Aspide Medical is based in LA TALAUDIERE (FRANCE). The studies are retrospective as they summarize testing that has already been performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the provided document. The performance data focuses on technical and material characteristics of a surgical mesh, not on expert interpretations of medical images or clinical outcomes that typically require ground truth established by experts.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where there might be disagreement in assessments. The reported tests are objective technical validations against established standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This document describes a medical device (surgical mesh), not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. This document describes a medical device (surgical mesh), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance testing cited are the established international standards (ISO, USP) for biocompatibility, sterility, packaging, and material characterization. The device's performance was compared against these universally recognized technical standards and against the specifications of predicate devices.
8. The Sample Size for the Training Set
This information is not applicable. This document describes a medical device (surgical mesh) testing and substantial equivalence, not the development or training of an AI model that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As no AI model or training set is mentioned, there is no ground truth for a training set to be established.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.